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Constipation Drug Is Approved

The Food and Drug Administration on Thursday approved a drug made by Ironwood Pharmaceuticals to treat chronic constipation and irritable bowel syndrome with constipation in adults.

The drug, linaclotide, will be sold under the brand name Linzess and carry warning that it should not be used by patients 16 or younger, the agency said.

An estimated 63 million people suffer from chronic constipation, according to the National Institutes of Health. Additionally, an estimated 15.3 million people cope with irritable bowel syndrome, which causes abdominal pain when accompanied by constipation.

Ironwood and a marketing partner, Forest Laboratories, said they expected the drug to be available for patients in the fourth quarter.

Gregory Wade, an analyst with Wedbush Securities, expects sales of Linzess to exceed $2 billion a year by 2019. However, he estimated sales of just $40 million in 2013, increasing to $165 million in 2014.

Shares of Ironwood Pharmaceuticals ended with a loss of 24 cents, or 1.9 percent, at 12.42 a share. Mr. Wade suggested that investors might want to see how sales perform before betting on Ironwood.

A version of this article appears in print on August 31, 2012, on Page B2 of the New York edition with the headline: Constipation Drug Approved. Order Reprints|Today's Paper|Subscribe